Clinical Trials in Mexico

There are about 2991 clinical studies being (or have been) conducted in Mexico.
The country of the clinical trial is determined by the location of where the clinical research is being studied.
Most studies are often held in multiple locations & countries.

The aim of the study is to assess safety, tolerability and clinical effects of different
doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension
(CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH
trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study
to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have
failed after standard therapy and for whom no therapy alternatives exist, in the time between
positive results and approval / availability on the market, and to collect safety data for
regorafenib until market access.
Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase
inhibitor targets certain key proteins that are essential for the survival of the cancer
cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The
growth of the tumor may be decreased by preventing these specific proteins from functioning.
The primary endpoint of this study will be safety.

This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia
who are resistant or intolerant to imatinib and to provide patients access to this new drug
until the drug becomes commercially available.

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Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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